510(k) K871116

X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R by X-Cel X-Ray Corp. — Product Code IYH

K871116 is an FDA 510(k) premarket notification submitted by X-Cel X-Ray Corp. for the device "X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code IYH (Generator, Dermatological (Grenz Ray), Therapeutic X-Ray), a Class II device regulated under 21 CFR 892.5900. X-Cel X-Ray Corp. has at least 3 other 510(k) clearances on record.